Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 11:59 AM
Ignite Modification Date: 2025-12-25 @ 11:56 AM
NCT ID: NCT05028361
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data was collected over 120 days (approximately 4 months).
Study: NCT05028361
Study Brief: Simultaneous mRNA COVID-19 and IIV4 Vaccination Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sequential Vaccination Group Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and saline placebo at Visit 1, IIV4 at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine. mRNA COVID-19: ACIP-CDC recommended vaccine IIV4: ACIP recommended vaccine Placebo: Saline Control 0 None 1 166 9 166 View
Simultaneous Vaccination Group Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and IIV4 at Visit 1, saline placebo at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine. mRNA COVID-19: ACIP-CDC recommended vaccine IIV4: ACIP recommended vaccine Placebo: Saline Control 0 None 1 169 18 169 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Spontaneous Complete Abortion NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Small Bowel Obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COVID-19 Illness NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View